Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Miglustat

EU orphan designation number: EU/3/06/351   
Active ingredient: Miglustat
Indication: Treatment of Niemann-Pick disease, type C
Sponsor: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Zavesca on 20/11/2002 with the number EU/1/02/238

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/02/2006 Orphan designation EMEA/OD/090/05 (2006)552 of 16/02/2006
02/07/2014 Change of name and/or address of sponsor